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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K200912
Device Name Freedom(R) - TiNbN Coated Knee
Applicant
Maxx Orthopedics, Inc.
2460 General Armistead Ave. Suite 100
Norristown,  PA  19403
Applicant Contact Priscilla Herpai
Correspondent
Maxx Orthopedics, Inc.
2460 General Armistead Ave. Suite 100
Norristown,  PA  19403
Correspondent Contact Priscilla Herpai
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/06/2020
Decision Date 11/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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